Impact of a Gluten-free Diet on Quality of Life in Patients With Axial Spondyloarthritis.

Study Purpose

Subclinical intestinal inflammation and gut dysbiosis have been reported in patients with
spondyloarthritis (SpA). In common practice, rheumatologists are increasingly confronted with
patients with inflammatory rheumatism who are on gluten-free diets (GFDs), despite the lack
of reliable data from controlled studies. This study aims to determine the impact of a GFD on
the quality of life of patients with axial SpA.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Interventional

Eligible Ages

18 Years and Over

Gender

All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- diagnosis of axial SpA defined by ASAS criteria
- Rheumatologist not wish to change the treatment within 4 months of inclusion,
- stable treatment (NSAID and/or DMARD) for at least 3 months but no corticosteroid
infiltration in the month prior to inclusion,
- able to follow a GFD and to provide written informed consent and submit to the
requirements of the study

Exclusion Criteria:

- Any diet at the time of inclusion or within 3 months prior to inclusion;
- have a history of celiac disease;
- received antibiotic treatment within 3 months of inclusion or are taking a probiotic;
- are pregnant, breastfeeding,
- not covered by social security;
- minors or adults under the protection of the law or under the protection of justice.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

The disease, disorder, syndrome, illness, or injury that is being studied.

Ankylosing Spondyloarthritis

Additional Details

The GlutenSpA study is a 24-week, randomized, double-blinded, placebo-controlled, multicenter
trial. Patients with axial SpA (n=200) will follow a 16-week GFD and be randomly assigned
(1:1) to an experimental or control arm. In the experimental arm with receive at least 6
gluten-free breads per day + 200 g of gluten-free penne pasta per week + 6 rice flavor
capsules per day. The control arm will receive at least 6 gluten-containing breads per day +
200 g of gluten-containing penne pasta per week + 6 vital gluten-containing capsules per day.
At baseline, the dietician will explain to the patients how to properly follow a GFD during a
face-to-face interview. The patient's compliance to the GFD will be evaluated by the
dietician at S2, S16, an S24 using an online 3-day alimentary questionnaire.
The bread and penne pasta were chosen for their visual resemblance and similar taste to
maximize the blindness of the study. In order to reach the daily amount of gluten in a
standard diet (estimated in France between 10 and 15 g/d) in the control arm, each day
patients will have to ingest six capsules of vital gluten wheat made for the study. Vital
gluten flour is an over-the-counter food supplement used to enrich a protein diet or as a
base for making products, such as seitan. Capsules will be made using commercially available
vital gluten and contain 0.35 g of gluten per capsule. The total amount of gluten in the
control arm will be approximately 10.5 g/day.
After the 16-week GFD, patients will be offered to follow or not follow the GFD according to
their own decision for an 8-week open-labelled follow-up period. The study duration for each
patient is 24 weeks. The patient recruitment is expected to last 2 years

Arms & Interventions

Arms

Experimental: experimental arm

In the experimental arm will receive at least 6 gluten-free breads per day + 200 g of gluten-free penne pasta per week + 6 rice flavor capsules per day

Active Comparator: control arm

the control arm will received 6 gluten-containing breads per day + 200 g of gluten-containing penne pasta per week + 6 vital gluten-containing capsules per day

Interventions

Dietary Supplement: - Gluten-Free Diet

Dietary supplement without gluten

Dietary Supplement: - Gluten Diet

Dietary supplement with gluten

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